We also use a commercial database management system — Oracle 11g.
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The integrated PASS-PC utilizes a standardized approach to data collection and reporting, and uses extensive validation procedures to prevent entering erroneous data. The final system has three main components: 1. NPSN myConnect portal; 3.
It has been built to meet the short term goal of gathering prostate cancer related data, but also with the prerequisites in place for future evolution into a cancer research informatics platform. In the future this will be vital for successful prostate cancer studies, care and treatment. Prostate cancer is a cancer that forms in tissues of the prostate a gland in the male reproductive system found below the bladder and in front of the rectum.source link
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It is the most common cancer affecting men in the United States. More than , new cases are expected to be diagnosed in [ 1 ]. The majority of diagnosed men will not have disease that will result in prostate cancer specific mortality; however, nearly 30, men will die from prostate cancer this year. The introduction of serum prostate specific antigen PSA screening around led to a transient increase in prostate cancer diagnosis. Furthermore, the pattern of initial presentation of patients shifted to men with low volume disease. The long natural history of this disease has been characterized [ 2 ] and as a result has raised concerns that there may be excessive use of local intervention in men with low risk disease.
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This is accentuated by the recognized morbidity of the various forms of local therapy. In , the initial report from the Veterans Administration sponsored PIVOT study [ 3 ] demonstrated a lack of mortality benefit for men with low-risk prostate cancer who underwent surgical intervention. Conversely, in ongoing active surveillance series, it has been shown that approximately one third of men deemed appropriate for active surveillance show evidence of progression that merits consideration of intervention while the remainder either remain stable and eventually terminate follow-up or, due to excessive anxiety, elect to proceed with therapy despite a lack of evidence of progression [ 4 ].
These data together underscore the need for understanding the natural history and biology of low-risk disease and the impact of the practice patterns of active surveillance on men with low risk disease.
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Several academic institutions have programs of active surveillance in which men with low-risk cancers have undergone intense observation. Low-risk cancers are typically those which 1 are small volume prostate cancers that cannot be felt on a prostate examination digital rectal exam and 2 lack aggressive histological morphology microscopic appearance. These active surveillance routines have been institution specific; as such, a more comprehensive active surveillance approach is necessary.
REDCap is a secure Web application for building and managing online surveys and databases. It employs a novel workflow methodology and the software solution is designed for rapid development and deployment of electronic data capture tools to support clinical and translational research [ 2 ].
OpenClinica is powerful software for collecting and managing clinical trial data. To carefully observe men active surveillance with screened detected low risk prostate cancer and manage them without immediate curative intervention. To explore urine and serum collected in order to develop and evaluate new and existing biomarkers for prostate cancer, evaluate biomarker changes, study gene expression profiles, and evaluate nuclear proteins.
Web-based data management systems offer great potential for facilitating the conduct of large scale or multi-center clinical studies [ 8 - 11 ]. Investigators and researchers working across multiple sites with varying infrastructure can access data and analytical tools in these systems on a real-time basis, minimizing the logistical challenges in multi-center collaboration, providing improved monitoring capability, and facilitating new mechanisms for producing high quality validated data [ 10 ].
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A confederation model assumes that each participating site retains all rights to the acquired data that can be used by other integrated PASS-PC participants only after obtaining required permissions and approved by its Institutional Review Board IRB. It is essential to have a standardized approach to data collection and reporting for this model to be successful.
Based on the legacy standalone MS Access database developed by John Hopkins, the integrated PASS-PC defines and establishes the criteria for standardization of collection forms and identified research questions that must be addressed. The core data elements include the most common questions used in clinical, nutritional, and quality of life studies.
Additionally, the core data set includes the following data elements: registering institution, staff member performing data entry, and patient identification code. Finally, the data definition language DDL script for Oracle database is generated from the data model. The process flow for the system model design is shown in Fig. Step 2. If no errors found in steps 2. Here, we use ArgoUML 0. These two databases exchange stored patient health information PHI in an encrypted format via Web Service call.
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